inforMED
MalfunctionKRR

MCK FEMORAL- RM-LL- SZ 6

Received Feb 18, 2015 · Event occurred Jan 19, 2015

Report 3005985723-2015-00015 · MDR key 4524724

Device

Generic name

Compartmental Knee Prosthesis

Catalog number

180516

Lot number

26030712-01

Product problems

  • Material Separation
  • Device Contamination with Chemical or Other Material
  • Material Integrity Problem

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT WAS COMPLETED AT MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION IS OBTAINED.

Additional Manufacturer Narrative

AN EVENT REGARDING FINDING SHAVINGS INSIDE OF THE PACK WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVALUATION AND RESULTS: VISUAL ANALYSIS CONFIRMED THE REPORTED EVENT. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED BECAUSE THERE IS NO INDICATION THE EVENT WAS RELATED TO PATIENT FACTORS -DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN OTHER SIMILAR REPORTED EVENT FOR THIS LOT ID. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT IMPLANTS RUB AGAINST THE TYVEK MATERIAL AND CREATES PARTICULATES IN THE POUCH. A CAPA WAS INITIATED TO EVALUATE PARTICULATES OBSERVED IN THE POUCHES AND FURTHER INVESTIGATE THE ROOT CAUSE. THE SOURCE OF THE DEBRIS WAS CONFIRMED TO BE THE TYVEK PACKAGING MATERIAL WHICH INTERFACES WITH THE ROUGH SURFACE OF THE CONTAINED IMPLANT. THE ROOT CAUSE OF THE DEBRIS WAS DETERMINED TO DUE FRICTION OCCURRING BETWEEN THE ROUGHENED POSTS OF THE IMPLANT AND THE TYVEK MATERIAL. DESIGN CHANGES TO THE STERILE PACKAGING WERE IMPLEMENTED IN AUGUST 2012 WITH TO CORRECT AND PREVENT THE GENERATION OF THE DEBRIS. THE REPORTED DEVICE WAS MANUFACTURED PRIOR TO THE IMPLEMENTED CHANGES AND IS THEREFORE WITHIN THE SCOPE OF CAPA.

Description of Event or Problem

AN IMPLANT THAT WAS TO BE USED FOR A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS WAS DEEMED UNFIT FOR USE AS THERE WERE SHAVINGS INSIDE OF THE PACKAGE. THE IMPLANT WAS NOT USED AND A NEW IMPLANT WAS OPENED AND USED. THIS EVENT DID NOT AFFECT THE OUTCOME OF THE CASE WHICH WAS SUCCESSFUL.

Description of Event or Problem

AN IMPLANT THAT WAS TO BE USED FOR A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS WAS DEEMED UNFIT FOR USE AS THERE WERE SHAVINGS INSIDE OF THE PACKAGE. THE IMPLANT WAS NOT USED AND A NEW IMPLANT WAS OPENED AND USED. THIS EVENT DID NOT AFFECT THE OUTCOME OF THE CASE WHICH WAS SUCCESSFUL.